Every year millions of men, women, and children of all ages suffer from urinary incontinence or involuntary loss of urinary control. For those suffering from urinary incontinence their lives are perpetually interrupted by thoughts of ensuring they have ready access to a restroom. Everyday activities such as visiting a movie theater or attending a sporting event can become unpleasant. Sufferers often begin to avoid social situations in an effort to reduce the stress associated with their condition.
There are five basic types of incontinence: stress incontinence, urge incontinence, mixed incontinence, overflow incontinence and functional incontinence. Stress urinary incontinence (SUI) is the involuntary loss of urine that occurs due to sudden increases in intra-abdominal pressure resulting from activities such as coughing, sneezing, lifting, straining, exercise and, in severe cases, even simply changing body position. Urge incontinence, also termed “overactive bladder” comprising the symptom of urgency, frequency with or without incontinence, usually with noturia in the absence of a contributing urological condition. This symptom complex is also associated with the terms “hyperactive bladder,” “frequency/urgency syndrome” or “irritable bladder,” occurs when an individual experiences the compelling need to urinate and loses bladder control before reaching the toilet. Urge incontinence can take the form of neurogenic detrusor hyperflexia, detrusor sphincter dyssnerigia, overactive bladder, benign prostatic hyperplasia (enlarged prostate), bladder neck obstruction and/or interstitial cystitis. Mixed incontinence is a combination of the symptoms for both stress and urge incontinence. Mixed incontinence is the most common form of urinary incontinence. Inappropriate bladder contractions and weakened sphincter muscles usually cause this type of incontinence. Overflow incontinence is a constant dripping or leakage of urine due to an overfilled bladder. Functional incontinence results when a person has difficulty moving from one place to another. It is generally caused by factors outside the lower urinary tract, such as deficits in physical function and/or cognitive function.
The bladder is composed of several layers of tissue which includes an 1) inner mucosal and submucosal layer, 2) a muscular layer composed of smooth muscle—the “detrusor”, and 3) a serosal layer. It is the muscosa and submucosa that contains many of the sensory nerves responsible for afferent sensory input that is associated with both sensation experienced as fullness or pain and is associated with the symptoms of urgency and frequency and that results in reflex efferent activity and detrusor contraction resulting in the sensory symptoms above and a rise in intravesical pressure that may result in incontinence.
A variety of treatment options are currently available to treat overactive bladder and incontinence. Some of these treatment options include external devices, behavioral therapy (such as biofeedback, electrical stimulation, or Kegel exercises), injectable materials, prosthetic devices and/or surgery. Surgery may take the form of intestinal augmentation of the bladder, implantation of a neuromodulator on the peripheral sacral nerves, or endoscopic injection of the detrusor. Depending on the age, medical condition, and personal preference, current surgical procedures can also be used to completely restore continence. However, as with any surgery there can be instances of long recovery periods and potential complications.
What is needed in the industry is a minimally invasive surgical system and method of treating overactive bladder in both male and female patients, that 1) provides a controlled pattern of injection, 2) provides a controlled number of injection sites, 3) provides a controlled depth of injection, 4) provides a controlled amount of injection, 5) makes endoscopy optional, and 6) that can be conducted on an inpatient or outpatient basis and lastly 7) exposes the patient to very little physical discomfort during the procedure.